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Staloral and Phostal

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Consumers and health professionals are advised that Stallergenes Australia, in consultation with the TGA, is recalling certain batches of Staloral and Phostal.

Staloral is a range of sublingual solutions and Phostal is a suspension for injection. Both medicines are used for allergen immunotherapy. Staloral is for a range of allergens and the affected batch of Phostal is used specifically for European dust mite (D.Pteronyssinus).

This recall follows a directive from the French health authority, Agence Nationale de Sécurité du Médicament (ANSM), to temporarily suspend manufacturing and distribution of pharmaceutical products and active ingredients for use in pharmaceutical products from the Stallergenes production plant in Antony (France), commencing 2 December 2015. Subsequently, the TGA have cancelled the manufacturing clearance for this site.

This decision was made after identification by ANSM that the implementation of a new IT system on 13 August 2015 could lead to these medicines having incorrect labelling that could result in incorrect dosing. It also caused operational disruptions and supply shortages. Any medicines manufactured before 13 August 2015 are not affected and can be used.

If the dosage for these medicines is incorrect, there is a potential for inadequate treatment, excessive dosage and/or allergic reaction.

As of 16 December 2015, there have been no reports of adverse events in Australia or outside of France associated with this issue.

The affected name/description and lot numbers are:

Staloral:

Product code

Product name/description

Batch no. start

Batch no. end

A400007246

D.PTERONYSSINUS

A315133501

A325450501

A400007248

DPTE/DFAR.50/50

A315249501

A325289601

A400007249

D.PTERONYSSINUS

A315165801

A325382401

A400007250

DPTE/DFAR.50/50

A315480401

A325293301

A400007252

DPTE/DFAR.50/50

A316120801

A400007253

DPTE/DFAR.50/50

A315134901

A325437001

A400007256

5 GRASSES MIX

A315141701

A325366501

A400007257

5 GRASSES MIX

A315200501

A325325801

A400007259

D.PTERONYSSINUS

A315141801

A325357101

A400007260

DPTE/DFAR.50/50

A315138401

A325399601

A400007262

DPTE/DFAR.50/50

A315190301

A325300901

A400007263

5 GRASSES MIX

A315466901

A325440801

A400007264

5 GRASSES MIX

A315849301

A325724401

A400007265

12 GRASSES MIX

A315229101

A325713901

A400007266

12 GRASSES MIX

A316230401

A324831401

A400007267

D.PTERONYSSINUS

A315184501

A325291901

A400007271

5 GRASSES MIX

A315248101

A325646501

A400007273

DPTE/DFAR.50/50

A318947501

A323020801

A400007275

D.PTERONYSSINUS

A316480601

A324822401

A400007280

DPTE/DFAR.50/50

A322045101

A400007281

CUPRESSACEAE

A317548601

A317548801

A400007287

D.PTERONYSSINUS

A317343401

A317343501

A400007939

DPTE/DFAR.50/50

A316179601

A323749001

A400008215

3 GRASSES MIX

A316999601

A400008216

5 GRASSES MIX

A319237901

A400008383

BIRCH

A317948001

A400008686

3 GRASSES MIX

A320570001

A400008728

3 GRASSES MIX

A325357201

A400009060

D.PTERONYSSINUS

A321881001

A400009114

D.PTERONYSSINUS

A324066401

A400009115

5 GRASSES MIX

A323998001

A400009459

3 GRASSES MIX

A323478901

A324040701

Phostal:

Product name/description - D.Pteronyssinus

Lot numbers - 2000277946 and 2000577822

Information for consumers

Health professionals who have prescribed/delivered Staloral or Phostal from one of the affected batches will contact those patients and provide further information about this issue. In some cases, Stallergenes Australia will contact patients directly.

If you or someone you care for is taking Staloral or Phostal from an affected batch (see product codes and lot numbers in the section above), stop using it and return it to the doctor or pharmacy where you obtained it as soon as possible. Refunds will be provided for all returned medicine from the affected batches.

If you have any questions or concerns about this issue, speak to your health professional. Alternatively, you can call Stallergenes Australia on 1800 635 306.

Information for health professionals

Stallergenes Australia has contacted health professionals who have prescribed/delivered Staloral or Phostal from the affected batches providing further information about this issue, including details regarding the recall process.

If you have prescribed Staloral or Phostal from one of the affected batches, contact those patients and advise them of this issue. Instruct them to stop taking the medicine and to return any unused product to you or to the pharmacy where they obtained it as soon as possible.

If you have any questions or concerns about this issue, contact Stallergenes Australia on 1800 500 499 (prescriber-only number).

Reporting problems

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.